PMA P990037S012

Device: DUETT PRO SEALING DEVICE AND THE DIAGNOSTIC DUETT PRO SEALING DEVICE SEALING DEVICE
Applicant: Vascular Solutions, Inc.
PMA number: P990037
Supplement: S012
Product code: MGB
Decision date: 2003-01-30
Classification: Device, Hemostasis, Vascular
Generic name: Device, hemostasis, vascular
Approval order statement: APPROVAL FOR A DESIGN CHANGE TO THE DUETT PRO SEALING DEVICE AND THE DIAGNOSTIC DUETT PRO SEALING DEVICE. SPECIFICALLY, 1) REMOVAL OF THE SILICONE GASKET FROM THE PRESSURE RELIEF VALVE DESIGN; 2) REMOVAL OF A LUER LOCK THREAD/ATTACHMENT WHICH WAS USED TO CONNECT THE CATHETER TO THE PRESSURE RELIEF VALVE AND REPLACE WITH AN ADHESIVE BOND; 3) REMOVAL OF THE CAP COVER AND THREADS FROM THE RELIEF VALVE, AND 4) SHORTENING OF THE LENGTH AND HEIGHT OF THE RELIEF VALVE.

Current openFDA PMA Record#

Device: DUETT PRO SEALING DEVICE AND THE DIAGNOSTIC DUETT PRO SEALING DEVICE SEALING DEVICE
Applicant: Vascular Solutions, Inc.
PMA number: P990037
Supplement: S012
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2003-01-30
Decision code: APPR
Date received: 2003-01-17
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A DESIGN CHANGE TO THE DUETT PRO SEALING DEVICE AND THE DIAGNOSTIC DUETT PRO SEALING DEVICE. SPECIFICALLY, 1) REMOVAL OF THE SILICONE GASKET FROM THE PRESSURE RELIEF VALVE DESIGN; 2) REMOVAL OF A LUER LOCK THREAD/ATTACHMENT WHICH WAS USED TO CONNECT THE CATHETER TO THE PRESSURE RELIEF VALVE AND REPLACE WITH AN ADHESIVE BOND; 3) REMOVAL OF THE CAP COVER AND THREADS FROM THE RELIEF VALVE, AND 4) SHORTENING OF THE LENGTH AND HEIGHT OF THE RELIEF VALVE.